Strafford will be offering a webinar/teleconference
entitled "Biosimilars: Draft FDA Guidance and Emerging Legal Challenges —
Navigating FDA's Approval Pathway, Patent Issues, and the Complexities of
Exclusivity" on October 23, 2012 from 1:00 – 2:30 pm (EDT).  Patent
Docs author Dr. Kevin Noonan of McDonnell, Boehnen, Hulbert & Berghoff
LLP and Howard W. Levine of Finnegan Henderson Farabow Garrett & Dunner
will provide IP attorneys with a review of the FDA draft guidance and the
complex standards of the FDA's Biosimilar Approval Pathway and will address
patent and exclusivity concerns around the development and marketing of
biosimilars..  The webinar will review
the following questions:

•
How will the draft guidance impact protection for biosimilars?
•
What are the FDA's definitions for "highly similar" and
"interchangeability"?
•
What are the market protection issues raised by patent exchange procedures for
biopharmaceuticals?
•
What is the criteria for the 12-year exclusivity period?

The
registration fee for the webinar is $297 ($362 for registration and CLE
processing).  Those registering by
September 28, 2012 will receive a $50 discount. 
Those interested in registering for the webinar, can do so here.